Fluconazole aflofarm

Patient Information Leaflet

Fluconazolum Aflofarm, 50 mg, hard capsules
Fluconazolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Fluconazolum Aflofarm is and what it is used for
2. What you need to know before taking Fluconazolum Aflofarm
3. How to take Fluconazolum Aflofarm
4. Possible side effects
5. How to store Fluconazolum Aflofarm
6. Contents of the pack and other information

1. What Fluconazolum Aflofarm is and what it is used for

Fluconazolum Aflofarm belongs to a group of antifungal medicines. The active substance is
fluconazole.
Fluconazolum Aflofarm is used to treat infections caused by disease-causing fungi and can also be used to prevent Candida infections. The most common cause of fungal infections are yeasts belonging to the genus known in Latin as Candida.
Indications
Adults
Your doctor may prescribe this medicine for the following fungal infections:

• cryptococcal meningitis – a fungal infection of the brain;
• coccidioidomycosis – a respiratory disease;
• Candida infections detected in the blood, internal organs (e.g. heart, lungs), or urinary tract;
• mucosal yeast infections (thrush) – infection of the mucous membranes of the mouth, throat, and denture-related stomatitis;
• genital yeast infections – infections of the vagina or penis;
• skin fungal infections – e.g. athlete’s foot, fungal infections of the trunk, groin, or nails.

Fluconazolum Aflofarm may also be used to:

• prevent recurrence of cryptococcal meningitis;
• prevent recurrence of mucosal yeast infections;
• prevent recurrence of vaginal yeast infections;
• prevent yeast infections (in patients with weakened or impaired immune systems).

Children and adolescents (aged 0 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:

• mucosal yeast infections (thrush) – infections of the mucous membranes of the mouth or throat;
• Candida infections detected in the blood, internal organs (e.g. heart, lungs), or urinary tract;
• cryptococcal meningitis – a fungal infection of the brain.

Fluconazolum Aflofarm may also be used to:

• prevent yeast infections (in patients with weakened or impaired immune systems);
• prevent recurrence of cryptococcal meningitis.

2. Important information before taking Fluconazolum Aflofarm

When not to take Fluconazolum Aflofarm:

• if the patient is allergic to fluconazole, to other antifungal medicines, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing;
• if the patient is taking astemizole, terfenadine (antihistamine medicines used to treat allergies);
• if the patient is taking cisapride (used to treat stomach disorders);
• if the patient is taking pimozide (used to treat mental disorders);
• if the patient is taking quinidine (used to treat heart rhythm disorders);
• if the patient is taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Before starting treatment with Fluconazolum Aflofarm, consult your doctor or
pharmacist if:

• the patient has impaired kidney or liver function;
• the patient has heart conditions, including heart rhythm disorders;
• the patient has abnormal blood levels of potassium, calcium, or magnesium;
• the patient experiences severe skin reactions (itching, skin redness, difficulty breathing);
• the patient develops symptoms of "adrenal insufficiency", when the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
• if the patient has ever experienced severe skin rash or skin peeling, blisters, and/or oral ulcers after taking Fluconazolum Aflofarm;
• if the fungal infection does not resolve, alternative antifungal treatment may be necessary.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Fluconazolum Aflofarm. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Fluconazolum Aflofarm must be discontinued immediately and medical help should be sought without delay.

Fluconazolum Aflofarm and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Immediately inform the doctor if the patient is taking:

• astemizole, terfenadine (antihistamines used in allergy treatment),
• cisapride (used to treat stomach disorders),
• pimozide (used to treat mental disorders),
• quinidine (used to treat heart rhythm disorders),
• erythromycin (an antibiotic used to treat infections),

as these should not be used together with Fluconazolum Aflofarm (see section "When not to take Fluconazolum Aflofarm").

The patient should inform the doctor if taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anaesthetic medicines),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• warfarin or similar medicines (medicines that reduce blood clotting, preventing blood clots),
• benzodiazepines (midazolam, triazolam or similar medicines) used to aid sleep or for calming effects,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat high blood pressure),
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used in cancer treatment,
• halofantrine (used to treat malaria),
• atorvastatin, simvastatin and fluvastatin or similar medicines (statins used to lower cholesterol levels),
• methadone (a painkiller),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - NSAIDs),
• oral contraceptives,
• prednisolone (a steroid),
• zidovudine, also known as AZT, saquinavir (used to treat HIV infection),
• chlorpropamide, glibenclamide, glipizide or tolbutamide (antidiabetic medicines),
• theophylline (a medicine used in asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders – "arrhythmias"),
• hydrochlorothiazide (a diuretic),
• citalopram, escitalopram (antidepressants), as fluconazole (an antifungal medicine) and cimetidine, lansoprazole and omeprazole (medicines used to treat peptic ulcer disease), fluvoxamine (an antidepressant) and ticlopidine (a medicine used to reduce the risk of heart attack) may increase their blood concentrations.

Taking Fluconazolum Aflofarm with food and drink
This medicine can be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

If the patient plans to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception.

For longer treatment courses with fluconazole, discuss with your doctor the need for appropriate contraception during treatment and for one week after the last dose.

If the patient is pregnant, suspects she may be pregnant, or is trying to conceive, she should not take fluconazole unless otherwise advised by a doctor.

If the patient becomes pregnant or suspects she may be pregnant during treatment with this medicine or within one week after the last dose, she should contact her doctor immediately.

• Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage.
• Fluconazole taken during the first trimester of pregnancy may increase the risk of congenital malformations of the heart, bones, and/or muscles.

Cases of infants born with congenital malformations of the skull, ears, and femur and elbow bones to mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least 3 months have been reported. The causal relationship between fluconazole use and these cases is not fully established.

• Breastfeeding may continue after a single dose of Fluconazolum Aflofarm of 200 mg or less. Breastfeeding should be avoided if the patient is taking multiple doses of Fluconazolum Aflofarm.

Driving and operating machinery
This medicine may affect the ability to drive and operate machinery. If dizziness or seizures occur, the patient should not drive or operate machinery.

Fluconazolum Aflofarm contains lactose monohydrate and sodium

Lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Fluconazolum Aflofarm

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
For doses that cannot be achieved with capsules of this strength, fluconazole medicines
are available in capsules of different strengths.
The capsule should be swallowed whole with a glass of water. Capsules are best taken
at the same time each day. For children who cannot swallow capsules and for young children
requiring precise dosing according to body weight, fluconazole syrup is available.
Recommended dosages, depending on the type of infection, are listed below.
Adults

Adolescents aged 12 to 17 years
Administer the dose prescribed by the doctor (as in adult patients or as in children).
Children up to 11 years of age
The maximum daily dose in children is 400 mg.
The dose will be determined based on the child's body weight in kilograms.

Dosage in children from 0 to 4 weeks of age
Children aged 3 to 4 weeks
The same dose as above, but administered every other day. The maximum dose is 12 mg per kg body weight every 48 hours.

Children under 2 weeks of age
The same dose as above, administered every 3 days. The maximum dose is 12 mg per kg body weight every 72 hours.

Elderly patients
The usual adult dose is administered, unless the patient has renal function impairment.

Patients with renal function impairment
The physician may adjust the dosage depending on renal function.

Accidental overdose of Fluconazolum Aflofarm
Taking too many capsules at once may cause feeling unwell. Immediate contact should be made with the emergency department of the nearest hospital. Symptoms of overdose may include disturbances in hearing, vision, and sensation, as well as thinking about things that are not true (hallucinations and paranoid behaviors). Symptomatic treatment may be indicated (supportive treatment to maintain vital functions and gastric lavage, if necessary).

Missed dose of Fluconazolum Aflofarm
Do not take a double dose to make up for a missed dose. If a dose has been missed, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose and do not take it.

If there are any further doubts regarding the use of this medicinal product, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
If any adverse reaction occurs, consult a doctor or pharmacist.
This also applies to adverse reactions not listed in this leaflet.
If any of the following symptoms occur in the patient, discontinue taking
Fluconazolum Aflofarm immediately and seek immediate medical help:

• sudden wheezing, difficulty breathing, or chest tightness;
• swelling of the eyelids, face, or lips;
• itching all over the body, skin redness, or red itchy blisters;
• skin rash (itchy red bumps on the skin);
• severe skin reactions, such as blistering rash (may also affect the mouth and tongue);
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Fluconazolum Aflofarm may affect the liver. Liver-related symptoms include:

• feeling tired;
• loss of appetite;
• vomiting;
• yellowing of the skin or whites of the eyes (jaundice).

Other adverse reactions may occur
Common (in 1 to 10 out of 100 patients):

• headache;
• abdominal pain, diarrhoea, nausea, vomiting;
• increased liver function test values;
• rash.

Uncommon (in 1 to 10 out of 1,000 patients):

• decrease in red blood cells causing paleness, weakness, and breathlessness;
• loss of appetite;
• insomnia, drowsiness;
• seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly as tingling, prickling, or numbness, taste changes;
• constipation, indigestion, bloating, dryness of the mouth;
• muscle pain;
• liver damage and yellowing of the skin and eyes (jaundice);
• blisters, urticaria, itching, increased sweating;
• feeling of fatigue, malaise, fever.

Rare (in 1 to 10 out of 10,000 patients):

• decrease in white blood cells involved in the body's defence against infections and blood cells helping to stop bleeding;
• red or purple skin discolouration, possibly due to reduced platelet count or changes in other blood cells;
• changes in blood biochemical parameters (elevated cholesterol, blood lipids);
• decreased potassium levels in blood;
• tremor;
• ECG abnormalities, heart rhythm disorders;
• liver failure;
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling;
• severe skin reactions, swelling of lips or face;
• hair loss.

Frequency not known (frequency cannot be estimated from available data):

• drug reaction with eosinophilia and systemic symptoms (DRESS). Characterized by skin rash, fever, swollen lymph nodes, increased white blood cell count (eosinophilia), and inflammation of internal organs.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fluconazolum Aflofarm

Keep the medicine out of sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
LOT - batch number
EXP - expiry date
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Fluconazolum Aflofarm contains

• The active substance is fluconazole. Each hard capsule contains 50 mg of fluconazole.
• The other ingredients are: monohydrate lactose, corn starch, sodium lauryl sulfate, anhydrous colloidal silicon dioxide, magnesium stearate; capsule shell (cap and body): titanium dioxide (E 171), sodium lauryl sulfate, gelatin, water; printing ink: shellac, yellow iron oxide (E 172).

What Fluconazolum Aflofarm looks like and contents of the pack
Fluconazolum Aflofarm, 50 mg: hard gelatin capsule size '4', 14.40 ± 0.40 mm in length, with white to almost white body and cap, marked with yellow print: “50” on the body and “FL” on the cap.
The medicine is packaged in a PVC/PVDC-Aluminium blister pack, placed in a cardboard box with a leaflet.
Pack contents: 7 or 14 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer/Importer
APL Swift Services (Malta) Ltd,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000,
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, n.o 19, Venda Nova,
2700-487 Amadora,
Portugal